FDA.report

TRAUMA FIXATION SYSTEMS

Primary DI
00880304293205
Brand
TRAUMA FIXATION SYSTEMS
Company
Biomet Orthopedics, LLC
Model
26-352348
Catalog number
26-352348
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HTYPIN, FIXATION, SMOOTH

Product Code Classifications

CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00880304293205PrimaryGS10
70880304293204Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304293205008803042932058803042932050880304293205
7088030429320470880304293204

GMDN Terms

TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags

DUNS number
129278169
Device count
6
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00889024706828Mini Baseplate Sizer Cannulated HandleSSI008562SSI0085622026-03-19
00889024706835Mini Baseplate Sizer 0 degree On-axis HandleSSI008561SSI0085612026-03-19
00887868551611StageOne Select4311904311902026-03-17
00887868551628StageOne Select4311914311912026-03-17
00887868551635StageOne Select4311924311922026-03-17
00887868551642StageOne Select4311934311932026-03-17
00887868551659StageOne Select4311944311942026-03-17
00887868551666StageOne Select4311954311952026-03-17
00887868551673StageOne Select4311964311962026-03-17
00887868551680StageOne Select4311974311972026-03-17
00887868551697StageOne Select4311984311982026-03-17
00887868551703STAGEONE SELECT4311994311992026-03-17
00889024706774Biomet®32-34169232-3416922026-03-12
00889024706781Biomet®32-14815332-1481532026-03-12
00889024706798Biomet®32-14815132-1481512026-03-12
00889024706804Biomet®32-34169732-3416972026-03-12
00889024706811Biomet®32-14814932-1481492026-03-12
00889024706484Vanguard®32-34702132-3470212026-02-27
00880304009615BMP CABLE CUTTER4980104980102020-05-23
00880304387676OPEN END CUTTER4980234980232020-05-23

Other Devices Sharing Product Codes

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24053613265496Steinmann PinGebr. Brasseler GmbH & Co. KGHTY2026-03-20
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00888867516564Arthrex®ARTHREX, INC.HTY2026-03-13
00888867516601Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543188Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543270Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543287Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543294Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543317Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543324Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543485Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543621Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543652Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543669Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543683Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543812Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543829Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543850Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543874Arthrex®ARTHREX, INC.HTY2026-03-13
24026704912432KMEDICTELEFLEX INCORPORATEDHTY2026-02-06
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06438394000025ActivaPin™Bioretec OyHTY2026-02-05
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06438394000049ActivaPin™Bioretec OyHTY2026-02-05
06438394000056ActivaPin™Bioretec OyHTY2026-02-05
06438394000063ActivaPin™Bioretec OyHTY2026-02-05
06438394000070ActivaPin™Bioretec OyHTY2026-02-05
06438394000087ActivaPin™Bioretec OyHTY2026-02-05
06438394000094ActivaPin™Bioretec OyHTY2026-02-05
06438394000100ActivaPin™Bioretec OyHTY2026-02-05